Medical technology firm LivaNova has received the US Food and Drug Administration (FDA) 510(k) approval for its Essenz Heart-Lung Machine (HLM).
LivaNova said that its Essenz device builds on 50 years of partnership with perfusionists, where it has worked together with more than 300 perfusionists around the world.
The system was designed based on its LivaNova S5 HLM, which offers interaction and visibility during cardiopulmonary bypass procedures.
It includes pumps that can be controlled individually for simple, straightforward operations and an HLM sensor that checks and confirms readiness before the CPB procedure.
Essenz HLM, together with Essenz Patient Monitor, includes the Essenz Perfusion System, which delivers a patient-personalised perfusion approach.
The Essenz Perfusion System offers data-driven decisions to improve both clinical workflows and the quality of patient care during cardiopulmonary bypass (CPB) procedures, said the company.
LivaNova chief executive officer Damien McDonald said: “A perfusion system acts as a patient’s heart and lungs during an open-heart procedure, so having the highest-quality system backed by the expertise of a skilled perfusionist is paramount.
“When we were designing Essenz, perfusionists told us they needed a system that gives them access to comprehensive data to drive more informed decision-making throughout the entire procedure.
“We’ve done that with Essenz. Through next-generation hardware and software, Essenz empowers perfusionists to better serve their patients with increasingly tailored care.”
LivaNova said that its Essenz Patient Monitor features accurate sensing technology and an intuitive dashboard to support individualised, data-driven patient care during a case.
It supports perfusionists in the implementation of goal-directed perfusion (GDP), a therapy used for reducing the risk of acute kidney injury.
The patient monitor offers an intuitive user interface and continuously records and displays data and events together to assist the perfusionist throughout a procedure.
The Essenz Perfusion System features an ergonomic design and can be adapted to the individual needs of patients, workflows, and users.
It comes with advanced cable management and a mast-mounted design that minimises distractions and keeps the area clean and hygienic.
The Essenz Perfusion System is supported by a responsive service team of dedicated, local engineers in more than 100 countries, along with a global support centre.
With the FDA approval, LivaNova intends to commence the commercial launch of Essenz in the US.
The company has recently received regulatory approvals for the Essenz HLM, from Health Canada, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
Furthermore, LivaNova plans to commence a broad commercial release of the Essenz system in Europe, after a limited commercial release was announced last month.
